what we do best

process development

Due to increased global competition, R&Ds are insanely expected to deliver cost effective and robust processes in time. This includes designing experiments by using statistical software which saves thousands of cumulative man hours and resources. It’s critical to know scale up factors for successful transfer of technologies from lab to pilot and pilot to manufacturing.

Design of experiments using validated softwares

(Upstream)

Mammalian and microbial upstream process

(Upstream)

Titre improvement

(Upstream)

Media selection, screening & optimisation

(Upstream)

Design of experiments using validated softwares

(Downstream)

Pre-treatment of cell free supernatant

(Downstream)

Filtration strategies for flux improvement

(Downstream)

Chromatography

(Downstream)

Enzyme/Chemical catalysis

(Downstream)

Bioconjugation

(Downstream)

Precipitation & Crystallisation

(Downstream)

Lyophilization

(Downstream)

Scale up & scale down studies

(Downstream)

Stability studies for DS, DP & intermediates

(Downstream)

Hold time stability studies

(Downstream)

process Characterization

We provide end to end solution for PC activities such as risk assessment, design of experiments, building statistical models and verification.

Pre-requisites for PC

Identification of CQAs

Risk assessment (FMEA)

Process re-definition

SDM protocols

Scale down model (SDM) qualification

PC design, protocols and execution

Statistical analysis & model building

Linkage studies

Deducing PAR for all CPPs

Design space definition

Model verification